ES2582180T3 - Electrode device - Google Patents

Abstract

Electrode device (1) for the application of a transcutaneous electrical stimulation on the surface of a section of the human ear (2), which has a retention element (3) that can be applied together or in the ear (2) as well as at least one electrode (4, 5), which is arranged in or next to an electrode holder (6), in which the retention element (3) has a linear guide (7), in which a retention bar (8) is arranged linearly movable in the direction of a longitudinal axis (L) of the retaining element (3), so that the electrode holder (6) is arranged on the retention bar (8), in which the electrode holder (6) has at least one support section (9), on which the electrode (4, 5) is arranged, in which the electrode (4, 5) has at least one cylindrical surface section (10) and / or in the form of a spherical section (11) and / or in a conical shape, characterized in that two support sections (9) are provided and / or axial elements (13) for the retention of an electrode (4, 5), which are arranged under an angle (β), which is between 140 ° and 180 °.

Description

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DESCRIPTION

Electrode device

The invention relates to an electrode device for the application of a transcutaneous electrical stimulation on the surface of a section of the human eye, which has a retention element that can be applied together or in the ear as well as at least one electrode, which it is arranged in or next to an electrode holder, in which the retention element has a linear gma, in which a retention bar is arranged linearly movable in the direction of a longitudinal axis of the retention element, so that in The retention bar is arranged in the electrode holder, in which the electrode holder has at least one support section, on which the electrode is arranged, in which the electrode has at least one cylindrical surface section and / or spherical section and / or conical shape.

It is known, in general, through invasive and non-invasive nerve stimulation, to exert an influence on its neurophysiological and neuroelectric quality and, therefore, on the function of the stimulated nerves. In this way, different disease states can be treated. There are numerous devices for both invasive stimulation and non-invasive stimulation.

The present invention is based on the method of transcutaneous electrical nerve stimulation. In this procedure, impulse currents of different forms of the current, amplitudes, duration of the impulses and frequencies are applied through the skin in different nerves and modify their state parameters advantageously.

An electrode device of the type mentioned at the beginning is known from DE 10 2010 054 165 B3. A similar electrode device is shown in EP 2 026 872 B1. Here, an electrode device is described, which comprises a housing that can be fully accommodated in the earpiece (ear pin). From this, two bent wire-shaped sections extend, these being configured as elastic spring fixing brackets. In this way, the electrode device can be carried through interlocking in the earpiece in the necessary position, so that the auditory canal can be propelled with a transcutaneous stimulation. Other stimulation devices are shown in publications DE 10 2005 003 735 A1, US 5 514 175 and DE 10 2010 015 277 A1.

Although the electrode device known above already leads to good treatment results, in practice certain disadvantages of the device have been revealed.

Since conditioned by nature, the electrode devices with their electrodes must be constructed very small, the mechanical stability of the necessary connections, in particular of the electrodes with their connection cables, has not been optimally resolved so far. Therefore, an insufficient electrode fixing support can be produced, which is favored by the fact that a very soft flexible material (especially silicone) must be inserted for the fixing support, in order to achieve a sufficient comfort of use. Sometimes, irreparable damage to the electrode contacts occurs with a corresponding mechanical load of the electrode device during its insertion into the ear canal.

Moreover, it has been recognized as inconvenient that it is difficult to adapt an existing electrode device, if necessary, to an individual size of the earpiece or in general of the finger. This sometimes leads to a high expense when the electrode device is applied or to an optimum comfort of use.

In addition, in many previously known electrode devices it is an inconvenience that can negatively influence the hearing ability.

Moreover, the quality of the electrode contact is sometimes not optimal, since the cutaneous areas occupied by the electrodes are not large enough. This results in many previously known solutions due to the way in which the electrodes are arranged in a support element.

Furthermore, it is desirable, in spite of the normalization of the stimulation devices, to provide measures to facilitate, in a simple and economical way, an adaptation of the stimulation device in an individual wave.

Therefore, the invention has the task of developing an electrode device of the type indicated at the beginning, such that the aforementioned drawbacks are solved. Therefore, an electrode device should be proposed, with which it is possible to apply the electrode device simply and comfortably. Hearing ability should be influenced as little as possible negatively in this case when using the electrode device. The quality of the electrode contact should be improved through optimal configuration. Why

The solution of this task through the invention is characterized in that two support sections and / or axial elements are provided for the retention of an electrode, which are arranged under an angle, which is between 140 ° and 180 °.

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In this case, preferably a cylindrical surface section and a surface section in the form of a spherical section and a conical surface section and a surface section in the form of a spherical section is provided.

A preferred solution provides that the electrode is configured cylindrical in its area directed towards the support section, so that in the cylindrical zone of the electrode, an area in the form of a spherical section is connected at its end zone away from the support section. In this solution, it can also be provided that the transition of the electrode from its cylindrical zone to the support section is formed by a conical zone, so that the cylindrical zone has a larger diameter than that of the support section.

The electrode holder can in this case have a retention section that proceeds from the retention bar, at the end of which two support sections are arranged that point in different directions with respective electrodes.

The at least one support section may have an axial element, on which it is placed, especially the electrode coupled. The electrode can be fixed in this case on the axial element by union of the material, in positive union and / or in friction union.

An alternative solution provides that the at least one support section is preferably configured together with the retention section by an injection molding process, the electrode being connected through the injection molding process in place with the support section .

The retention section may have a longitudinal axis, which forms an angle with the longitudinal axis of the retention element, which is between 20 ° and 80 °, preferably between 40 ° and 70 °.

A preferred configuration of the invention provides that the two support sections and / or axial elements are arranged at an angle between 165 ° and 175 °.

In addition, it can be provided that the retention element comprises a support piece that is configured and intended for support in the Cavum conchae of the ofdo.

The electrode holder is arranged most of the time at an axial end of the retention bar.

The electrode holder has, specially configured as an electrode head, preferably at least one stimulation electrode and at least one reference electrode.

The linear grating of the retaining element can be formed by a recess, which has a constant shape, in particular a circular shape, in a section perpendicular to the longitudinal axis along the longitudinal axis, preferably with at least one part of its extension a circular cross section.

In addition, additionally or alternatively, fixing means can also be provided, which block the relative linear position between the retention element and the retention bar, that is, the linear displacement by means of the linear grid.

In addition, spring means can be arranged between the linear grid and the retention bar, so that the retention bar can be elastically tensioned relative to the linear grid in the direction of the longitudinal axis.

In general, it can be envisaged that, through corresponding measurements, a desired elasticity of the electrode holder is achieved in relation to the retention element. The aforementioned integration of a spring element is here only one possibility. Through suitable constructive measures it can also be achieved that the elasticity or the spring constant is in a desired area. In this way it is possible, for example, to reinforce the section of the retention bar through a sheet of metal spring and at the same time recover the material of the retention bar in this area or completely dispense with it. The spring leaf enables spring elasticity in a defined direction, while the union between the retaining element and the electrode holder remains stronger in other directions of the load.

From the above, it is understood that the concept of the "retention bar" can be interpreted here in a broad sense and is not limited in any way to classical bar-shaped structures.

The retention bar may have an axial end zone, in which the electrode holder is arranged, in addition to at least one lateral notch or at least one lateral incision, to reduce the flexural resistance of the bar in the axial extreme zone of retention in a direction perpendicular to the longitudinal axis. This facilitates the adaptation of the electrode holder to the topography of the skin surface to be stimulated.

The annular section of the support piece may have an opening in at least one circumferential place. In this way it can be achieved that there is a simplified adaptation of the circular ring section to the

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support area in the ofdo in different sizes of o ^ two.

The parts of the electrode device are preferably constituted - when there is contact with the skin - of a soft material, especially thinking of an elastomeric material, especially silicone or a material that has silicone. However, the electrode head and the retention bar are preferably constituted of a thermoplastic or duroplastic material, for example polyurethane.

It is mentioned that the proposed electrode device may also have only one electrode. It is possible that a separate reference electrode is used, which is located outside the electrode device (for example, behind the finger) and is in electrical connection with the stimulation apparatus. It is also possible that, in effect - as in the embodiment example - two or more electrodes are present, however, using another reference electrode outside the electrode device.

Another development provides that the electrode device is provided, preferably in the area of the support piece or its section in the form of a ring with an acoustic transmitter (loudspeaker). In this way, it is also possible to transmit acoustic signals during electrical stimulation to the user of the electrode device, which can also be done for maintenance purposes.

It is advantageous that a very stable construction is achieved through the proposed configuration of the electrode device, without negatively influencing the comfort of use. The electrodes are held stably and reliably in the necessary position, since they are arranged on the retaining bar in the relatively stable retaining element.

Through the two-piece construction type, it is possible, at the same time, to combine the retention bar together with the electrode head on one side with the retention element on the other side. This opens the possibility of combining elements of different sizes between sf. A preferred supply equipment therefore provides for more than one retention bar together with the electrode head and / or more than one retention element. The user can then select the elements with the optimum size for their relationships and assemble them, to have an optimal adapted electrode device.

In particular, the retention elements can easily be adapted to different sizes of different sizes or forms of different types. The head of the electrode or the electrodes rest in this case always with a defined pressure on the skin.

Examples of realization of the invention are shown in the drawing. In this case:

Figure 1 shows in perspective an electrode device according to the invention.

Figure 2 shows in perspective view the electrode device according to figure 1, considered from the front.

Figure 3 shows in perspective view the electrode device according to figure 1, seen from the front.

Figure 4 shows the top plan view on the front section of the electrode device according to Figure 1.

Figure 5 shows in perspective view the electrode device according to figure 1, seen from the front.

Figure 6 shows in perspective view the front section of the electrode device according to Figure 1, in the

that the electrodes themselves are disassembled.

Figure 7 shows in perspective view the front section of the electrode device according to Figure 1.

Figure 8 shows the side view of the front half of the electrode device according to Figure 1 with a first configuration of a ring-shaped contact element.

Figure 9 shows the side view of the front half of the electrode device according to Figure 1 with a second configuration of an annular contact element.

Figure 10 shows the side view of the front half of the electrode device according to Figure 1 with a third configuration of an annular contact element.

Figure 11 shows in perspective view the electrode device according to figure 1.

Figure 12 shows in perspective view the front part of the electrode device according to Figure 1, seen from another direction.

Figure 13 shows the view of an wave with an electrode device, which is inserted into the wave.

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Figure 14 shows the representation according to figure 13, seen from another direction.

Figure 15 shows the side view of the electrode device according to Figure 1.

Figure 16a shows a part partially represented in section of a support part of the electrode device, with an annular contact element according to a first embodiment.

Figure 16b shows a part represented in section of the annular contact element according to a second embodiment.

Figure 16c shows a part represented in section of the annular contact element according to a third embodiment, and

Figure 17 schematically shows in the side view a retaining means, which are effectively arranged between a retaining element and a retaining bar of the electrode device.

Figure 1 shows an electrode device 1 in the form of an otoplastic, which can be used in an eye 2 represented in Figures 13 and 14, respectively, of a person, to be able to perform a transcutaneous electro stimulation of the surface of the skin in the area of the finger.

With the electrode device 1, a transcutaneous electrical stimulation of the nerves is carried out in particular on a surface area of the finger. To this end, the electrode device has a stimulation electrode and a reference electrode (see below), among which an electric potential is generated; the means necessary for this have long been known in the state of the art, so they should not be described here again. As an example, reference is made to DE 10 2005 003 735 B4 of the applicant and express reference is made thereto.

The electrode device 1 has as its essential components a retention element 3 as well as a retention bar 8. The retention bar 8 carries an electrode holder 6 at an axial end on a joint element 22, which is provided with two electrodes 4, 5, namely, with a stimulation electrode 4 and a reference electrode 5 (of the same construction). The electrode holder 6 keeps the two electrodes 4, 5 at a desired distance and is configured between the electrodes 4, 5 as a bridge element. The retaining element 3 has a central section, which is dominated by a linear grid 7, which is formed by sections of parts 3 and 8. In this case, it is a section of material that extends in a longitudinal direction L in the form of a bar, in which a circular recess 23 is formed.

At the front end of the retaining element 3 a support piece 14 is formed integrally. The support piece 14 has an annular section 15 (see especially Figure 16). The annular section 15 is surrounded by an annular contact element 16, which is made of soft material and rests on the surface of the skin, as can be seen from Figure 13.

In this case it is essential that the retaining element 3 by means of the linear rail 7 is in a position to linearly move the retaining bar 8 in the direction of the longitudinal axis L.

In this way, it is possible to modify the distance between the electrode holder 6 and the electrodes 4, 5 and especially the support piece 14 and adjust it to the desired measurement.

This possibility of adjustment is used to regulate the electrode device after the location in the 2-fold, so that it finds with good comfort of use an elastic retention in the 2-wave.

To this end, reference is made to Figure 13 and Figure 14. Here it can be seen that the electrode device 1 has been inserted in the opening 2 and has been adjusted by means of linear displacement of the retaining bar 8 in relation to the retaining element 3, so that the electrode device 1 has been fixed elastically tensioned by virtue of the topology of the eye 2. Specifically, the electrode device 1 was arranged in the earpiece of the finger 2 in such a way that the holder electrodes 6 is placed in the area of Cymba conchae Cy, while the support piece 14 rests are its annular contact element 16 in the area of the Cavum conchae Ca.

Accordingly, the annular contact element 16 can be placed under the Tragus.

Due to a spring elasticity (conditioned by the material) of the retention bar 8 or due to a spring element integrated if necessary in the retention bar 8 (for example, spring wire), it is elastically pressed from this the electrode device 1 after the corresponding linear adjustment of the retaining bar 8 in relation to the retaining element 3, so that there is sufficient retention in the finger. As can be seen in Figure 13, the annular configuration of the annular contact element 14 allows a large-scale hearing without interference.

As can also be seen, in figure 1, the retention bar 8, by virtue of its conformation in relation to

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retaining element 3, is not rotatable about the longitudinal axis L. This is achieved by means of a zipper-shaped contour 17, which is formed integrally in the retaining bar 8 and passes through a recess that extends radially from the circular recess 23 of the retaining element 3. A section of the retaining element 3 is also configured as a fitting 18 (see FIG. 17 in this respect), so that through the contour 17 in the form of a zipper, on the one hand, and the engagement element 18, on the other hand, retention means are formed, by means of which the retention bar 8 can be moved relative to the retention element 3 of the ratchet type, that is, step step linearly in the direction of the longitudinal axis L.

An essential aspect of the present invention is the configuration of the electrodes 4, 5 in the electrode holder 6. As can be seen better in Figure 2, the electrodes 5, 6 have a conformation, which is composed of a cylindrical section 10 and a section 11 in the form of a spherical section. Spherical sections may also be provided additionally or alternatively. In this way it is possible that the electrodes - depending on the tightening pressure - acquire relatively large areas of the surface of the skin, that is, they have a large support surface on the skin, which correspondingly favors stimulation transcutaneous The electrodes 4, 5 are configured accordingly in any case by ellipsoid sections or in the form of beads. Advantageously, an improved adaptation of the electrodes to the given anatoirna of the finger results.

A possible application of the electrodes 4, 5 in the electrode holder 6 is deduced from Figures 3 to 7. Accordingly, the electrode holder 6 comprises a retention section 12, in which two sections are arranged of support 9. Each support section 9 has - see in this regard Figure 6 - an axial element 13, on which an electrode 4, 5- can be coupled respectively. To this end, electrode 4, 5 has a corresponding hole 24 (see figure 7), so that after the coupling of the electrodes 4, 5 on the axial elements 13 according to figure 6, the arrangement can be recognized in figures 3, 4, 5 and 7.

In this context it is indicated that the two support sections 9 or axial elements 13, which are seen, for example, in Figures 4, 5 and 6, are arranged under an angle that opens towards the skin just below 180 ° - in the exemplary embodiment they are approximately 170 ° -, in ways that ensure optimal support of the electrodes on the skin - This angle is indicated in Figures 4 and 6 with p.

The electrodes 4, 5 can be fixedly glued in this case, for example, on the axial elements 13.

An alternative solution provides that the electrodes 4, 5 are injected at the same time during injection molding of the electrode holder 6 together with the support sections 9. Therefore, the electrodes are not then surrounded by injection then already in a favorable manner, but they are arranged on a plastic soul. Therefore, the arrangement of the electrodes is optimally positioned for the intended purpose.

From the comparison of Figures 8 to 12 and 16, another very advantageous configuration of the invention results: the support piece 14 is constituted by an annular section 15, which is surrounded by an annular contact element 16 placed on top detachably . For the contact element 16 which is constituted of soft material, various forms are possible in this case, as can be recognized once from Figures 8, 9 and 10 and similarly also from Figures 16a, 16b and 16c, where respective sections are represented.

The conformation of the annular section 15 is congruent with the shape of the annular contact element 16. A slightly conical conformation 25 of the radially outer area of the annular section 15 is provided, in addition a recess 26 is provided in the annular section 15. The annular section 16 is configured congruent therewith, so that it can be recessedly coupled over the annular section 15 and thus finds sufficient retention here.

In Fig. 15 it can be recognized that the retaining section 12 of the electrode holder 6 has a longitudinal axis M, which cuts the longitudinal axis L under an angle a, which is in the embodiment example at approximately 65 °. In this way, the electrodes are arranged at an acute angle with respect to the bearing surface.

As can also be seen, in Figure 17, the gear element 18 forms a fixed section of the retention element 3, which is retained on incisions in the material of the retention element and, therefore, is elastically retained. On the side directed towards the contour 17 in the form of a zipper, three gears 19, 20 and 21 are integrally formed in the gear element 18. These are made staggered with respect to their height (see heights hi, h2 and tb), of so that the retention function is mainly determined by tooth 19 and only then supported by teeth 20 and 21.

At the radially outer end of the section with the zipper-shaped contour 17 of the retention bar 8, several retention means 27 are integrally formed in the form of annular structures, which serve to retain a cable 28 discharged by traction (preferably lizo Kevlar 3-wire and surrounded by biocompatible material), which supplies current to the electrodes 4, 5. The retention means 27 therefore serve as cable grommet eyelets, in which conduction and discharge of pull the cable 28. The cable 28 can be injected in this case at the same time during the injection of the pieces 8, 17 and 27 made in one piece.

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During the manufacture of the electrode holder 6 through injection molding, the cable 28 is similarly injected at the same time to achieve a tight seal of all seams.

In the retention bar 8, a joint element 22 is connected - as a junction section with the electrode holder 6 - which has the function of guiding the electrode holder 6 from the height, in which the linear gma 7 is located , towards the surface of the skin to be stimulated. As already explained, this must be done in such a way that the electrode holder 6 presses elastically against the surface of the foot and preferably also generates a pre-tension in the direction of the longitudinal axis L.

To this end, being uses a material for the joining element 22, which has the desired elasticity; This element therefore has preferably spring elastic properties. It is also possible that the connecting element 22 integrates a spring element. In this case, it can be, for example, a spring wire, which is surrounded by injection during injection casting of the retaining bar 8 together with the connecting element 22. As can be recognized, for example, to From figure 1, the connecting element 22 is not configured in the circular cross-section, but flattened. In this way the elasticity of the electrode holder 6 is raised in a perpendicular direction the longitudinal axis L.

In this case, the selection of the material, if necessary the integration of a spring element and the geometric conformation of the retention bar is carried out technically in such a way that the desired elasticity exists.

List of reference signs

1 electrode device

2 Ofdo

3 Retention element

4 Electrode (stimulation electrode)

5 Electrode (reference electrode)

6 Electrode holder

7 Gma linear

8 Retention bar

9 Support section

10 Cylindrical electrode section

11 Electrode section in the form of a spherical section

12 Retention section

13 Axial element

14 Support piece

15 Annular section

16 Ring contact element 17, 18 Retention means

17 Zipper-shaped contour / contour configured as a wavy track

18 Gear Element

19 Tooth

20 tooth

21 Tooth

22 Union Element

23 Circular recess

24 drill

25 Conical conformation

26 Notch

27 Retention medium

28 Cable

L Longitudinal axis

M Longitudinal axis of the retention section

to Angle

P Angle

Ca Cavum conchae

Cy Cymba conchae

T Tragus

P Headset

Claims (10)

5 10 fifteen twenty 25 30 35 40 1. - Electrode device (1) for the application of a transcutaneous electrical stimulation on the surface of a section of the human ear (2), which has a retention element (3) that can be applied together or on the finger (2) as well as at least one electrode (4, 5), which is arranged in or next to an electrode holder (6), in which the retaining element (3) has a linear gma (7), in that a retaining bar (8) is arranged linearly movable in the direction of a longitudinal axis (L) of the retaining element (3), so that the electrode holder (6) is arranged in the retaining bar (8) ), in which the electrode holder (6) has at least one support section (9), on which the electrode (4, 5) is arranged, in which the electrode (4, 5) has at least one cylindrical surface section (10) and / or in the form of a spherical section (11) and / or in a conical shape, characterized in that two support sections (9) and / or axial elements (13) are provided for the retention of an electrode (4, 5), which are arranged under an angle (P), which is between 140 ° and 180 °. 2. - Electrode device according to claim 1, characterized in that the electrode (4, 5) is configured cylindrical (10) in its area directed towards the support section (9), in which in the cylindrical area of the electrode ( 4, 5) an area (11) is connected in the form of a conical section at its end zone away from the support section (9). 3. - Electrode device according to claim 2, characterized in that the transition of the electrode (4, 5) from its cylindrical zone (10) to the support section (9) is formed by a conical zone, in which the zone cylindrical (10) has a diameter larger than that of the support section (9). 4. - Electrode device according to one of claims 1 to 3, characterized in that the electrode holder (6) has a retention section (12) that proceeds from the retention bar (8), at which end they are arranged at minus two support sections (9), which point in different directions, with respective electrodes (4, 5). 5. - Electrode device according to one of claims 1 to 4, characterized in that the at least one support section (9) has an axial element (13), on which it is applied, especially the electrode (4, 5). ). 6. - Electrode device according to claim 5, characterized in that the electrode (4, 5) is fixed on the axial element (13) by union of the material, in positive union and / or in friction union. 7. - Electrode device according to one of claims 1 to 4, characterized in that the at least one support section (9), preferably together with the retention section (12), is configured by an injection casting process , the electrode (4, 5) being connected by the injection molding process in place with the support section (9). 8. - Electrode device according to one of claims 1 to 7, characterized in that the retention section (12) has a longitudinal axis (M), which forms with the longitudinal axis (L) of the retention element (3) a angle (a), which is between 20 ° and 80 °, preferably between 40 ° and 70 °. 9. - Electrode device according to one of claims 1 to 8, characterized in that the two support sections (9) and / or axial elements (13) are arranged under an angle (P) between 165 ° and 175 °. 10. - Electrode device according to one of claims 1 to 9, characterized in that the retention element (3) comprises a support piece (14), which is configured and intended for support in the Cavum conchae (Ca) of the ofdo (2).